Clinical Trial

The Osteoarthritis Prevention Study

Study acronym: TOPS
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-07-06; most recent amendment 2026-07-21.
Status change: Not Yet Recruiting → Recruiting 2024-04-11
Trial Details
NCT Number NCT05946044
Lead Sponsor Wake Forest University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation, National Center for Complementary and Integrative Health (NCCIH), Office of Disease Prevention, Office of Research on Women's Health (ORWH), Office of Behavioral and Social Sciences Research (OBSSR), Centers for Disease Control and Prevention, University of Missouri-Columbia, Rapid Nutrition PLC
Conditions Osteoarthritis, Knee
Enrollment 1,230 participants
Start Date 2024-03-21
Primary Completion 2029-07-31 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-23